Pharmacovigilance Medical Writing: A Good Practice Guide - Couverture souple

Orleans-Lindsay, Justina

Couverture souple

ISBN 10 : 1119967260 ISBN 13 : 9781119967262

Editeur : Wiley-Blackwell, 2012

Synopsis

Pharmacovigilance Medical Writing covers the preparation of pharmacovigilance documents for all stages of the drug development process (i.e. from clinical development through to applications for marketing authorisations to the post-marketing stage). For each document, the book presents a review of the regulatory framework that governs the content of the document, followed by practical guidance (e.g. scheduling, source data, department/functions involved in document preparation/review, appropriate timelines and planning activities), ending with a generic model document compliant with the current guidelines, which can be modified to meet specific company and product requirements.

A propos du livre

À propos de l'auteur

Justina Orleans-Lindsay BSc, MSc, PhD is a Director of Acadustri (Medical Writing) Limited and Visiting Lecturer in pharmacovigilance at the University of Hertfordshire, UK.

Détails de l'édition

• Éditeur: Wiley-Blackwell
• Date d'édition: 2012
• Langue: anglais
• ISBN 10: 1119967260
• ISBN 13: 9781119967262
• Reliure: Broché
• Numéro d'édition: 1
• Nombre de pages: 288
• Coordonnées du fabricant: non disponible
• Personne responsable: non disponible